The aim of this study was to the effect of twelve weeks aerobic exercise on ovarian androgens and body composition of women with polycystic ovary syndrome. In this clinical trial 20 patients obese (BMI>25 kg/m2) and 20 patients lean (BMI<20 kg/m2) with Polycystic Ovary Syndrome were selected. Lean and obese subjects were randomly divided into intervention and control equally groups. The intervention group subjects were performed 12 weeks, 3 sessions per week with intensity 65-80% of maximal heart rate for 25 - 30 minutes of aerobic exercise, but intervention was not performed in control group. BMI, WHR, LH, FSH, Prolactin and Testosterone hormones were measured before and after of study. The data were analyzed using the Paired T and independent T tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212127255N4
Registration date:2012-12-23, 1391/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Sadegh Satarifard
Name of organization / entity
Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3866
Email address
satarifard@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2011-12-23, 1390/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of twelve weeks aerobic exercise on ovarian androgens and body composition of women with polycystic ovary syndrome
Public title
The effect of exercise in the treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age range 16 to 40 years; body mass index less than 20 and more than 25; at least two of the symptoms of PCOS; no ovulation or oligomenorrhea; hirsutism (above 8) and clinical or biochemical hyperandrogenism; Exclusion criteria: Patients undergoing treatment for menstrual disorders; antiepileptic drugs; contraceptives; pregnancy or weight loss drugs; those with hepatitis; pulmonary-cardiac disorders; diabetes; pregnancy; hypo-and hyperthyroidism Cushing's syndrome and adrenal hyperplasia.
Age
From 16 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan University of Medical Sciences
Street address
Next to the Governor, Shahid Chamran Boulevard, BandarAbbas
City
BandarAbbas
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
132
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Blood Prolactin
Timepoint
Before and after of intervention
Method of measurement
By method of chemoluminescence using Liaison kit
2
Description
Blood Testosterone
Timepoint
Before and after intervention
Method of measurement
By Elisa kit of ROTH
Secondary outcomes
empty
Intervention groups
1
Description
Twelve week aerobic exercise in intervention group
Category
Other
2
Description
The control group did not participate in the exercise program
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's Specialized Hospital in Bandar Abbas
Full name of responsible person
Satarifard Sadegh
Street address
Tehran University School of Physical Education, Kargrshmaly Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Satarifard Sadegh
Street address
Tehran University School of Physical Education, Kargrshmaly Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Satarifard Sadegh
Position
PhD student
Other areas of specialty/work
Street address
Tehran University School of Physical Education, Kargrshmaly Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8863 3866
Fax
Email
satarifard@ut.ac.ir satarifard@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Satarifard Sadegh
Position
PhD student
Other areas of specialty/work
Street address
Tehran University School of Physical Education, Kargrshmaly Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8863 3866
Fax
Email
satarifard@ut.ac.ir satarifard@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Satarifard Sadegh
Position
PhD student
Other areas of specialty/work
Street address
Tehran University School of Physical Education, Kargrshmaly Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8863 3866
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)